The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE) due to a narrow therapeutic window leading to important medical and economical consequences. The risk of ADE is increased partly by drug interactions and recently identified genetic factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9) as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide reductase complex subunit 1 (VKORC1).

The objective is to determine the impact of several genotypes on acenocoumarol treatment and on vulnerability to drug-drug interactions.

Length of hospitalisation in days [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Potential of other drug interactions, linked to the observed genotype and phenotype of the patient [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Whole blood samples

Enrollment:

115

Study Start Date:

November 2008

Study Completion Date:

March 2012

Primary Completion Date:

March 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Hospitalized patients starting acenocoumarol therapy

Criteria

Inclusion Criteria:

Every patients with requiring acenocoumarol therapy for at least 4 weeks and a target INR in the low intensity range (INR range 2-3)

Age ≥ 18 years

Signed informed consent

Exclusion Criteria:

Severe cognitive impairment

Previous or current treatment with any coumarin

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492777